Safety and tolerability of high-intensity focused ultrasonography for noninvasive body sculpting: 24-week data from a randomized, sham-controlled study

Abstract

Background: High-intensity focused ultrasonography (HIFU) is a nonsurgical, noninvasive method for body sculpting in nonobese patients. The technique ablates subcutaneous adipose tissue by causing molecular vibrations that increase tissue temperature and induce rapid cell necrosis. Objectives: The authors evaluate the long-term safety of a HIFU device for sculpting the abdomen and flanks. Methods: Adults with subcutaneous abdominal fat ≥2.5 cm in thickness who met screening criteria were randomized to receive HIFU treatment of the anterior abdomen and flanks at 1 of 3 energy levels (3 passes per patient): 47 J/cm2 (141 J/cm2 total), 59 J/cm2 (177 J/cm2 total), or 0 J/cm2 (no energy applied; sham control). Safety was assesed for 24 weeks and included laboratory testing, physical examinations, and documentation of adverse events. Results: Adverse events (AE) included mild to moderate discomfort, ecchymosis, and edema, all of which were transient. There were no reports of scarring or burns and no clinically meaningful changes in lipid panel findings, inflammatory markers, or renal or hepatic function. Physical examination results were unremarkable. Conclusions: This HIFU device exhibited an AE profile similar to that of sham treatment. There were no significant changes from baseline in laboratory values, including lipid levels. © 2012 The American Society for Aesthetic Plastic Surgery, Inc.